RESTORE-TAVI Pilot

Frailty Clinical Trial

Official title:

A Pilot Study Assessing the Feasibility and Effectiveness of a Perioperative Multi-component Intervention in Patients With Acute Decompensated Aortic Stenosis Undergoing Urgent Transcatheter Aortic Valve Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06121921
• Other study ID #: 330818
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Barts & The London NHS Trust
• Contact: Max Sayers
• Phone: 02073777000
• Email: max.sayers[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot randomised control study assessing the feasibility and effectiveness of a perioperative multi-component intervention aimed at reducing adverse hospital events and improving functional outcomes in patients with acute decompensated aortic stenosis undergoing urgent transcatheter aortic valve implantation compared to standard care. The intervention will consist of physical rehabilitation, delirium prevention, nutritional supplementation and anaemia correction (where indicated). The primary objective is to determine the feasibility and safety of delivering this intervention Secondary objectives include investigating the impact on adverse hospital events such as hospital-acquired disability and post-TAVI delirium, and on health-related quality of life and functional recovery following TAVI.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

1. Age > 70 years

2. Ability to provide written informed consent

3. Ability to speak English

Exclusion criteria:

1. Clinical instability defined as requiring use of inotropes/mechanical-circulatory support during admission or post-cardiac arrest

2. Active delirium (4AT score = 4) at time of recruitment

3. Parkinson's disease (Hoehn & Yahr stage 3-5)

4. Recent stroke (within 7 days preceding recruitment)

5. Terminal condition (e.g. metastatic cancer) with life expectancy < 12 months

6. Clinical unsuitable for recruitment to trial according to the discretion of the research team

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic
• Frailty

Intervention

Other:
• Perioperative multi-component intervention
Physical Component Self-directed daily non-ambulatory exercise programme, comprising: Rubber ball squeezes (3 sets of 12 reps, per hand) Bicep curls (3 sets of 12 reps) Leg extensions (3 sets of 12 reps) Chair rises (3 sets of 12 reps) Arm stretches (3 sets of 3 reps) Additional encouragement to mobilise Cognitive Component: Delirium prevention strategies including orientation, hydration, bowel/bladder function, infection control, analgesia, polypharmacy and cognitive stimulation Nutritional Component: Formal dietician review if MUST score = 2 IV ferritin if LVEF <45% and serum ferritin <100ng/mL or ferritin 100-299ng/mL with TSAT <20%

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Barts & The London NHS Trust	Imperial College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Recruitment rates	Average number of patients per month willing to give informed consent and be randomised into a trial of a perioperative frailty intervention	1 year
Primary	Feasibility: Safety	In-hospital adverse events (e.g. falls, ischaemia, arrhythmia, acute kidney injury), in-hospital mortality	On discharge: e.g. 2-7 days
Secondary	Incidence of hospital-acquired disability	defined as loss of = 1 ADL at discharge compared to admission; and followed-up at 30 days after discharge	30 days
Secondary	Incidence of delirium	Assessed daily during hospitalisation by using 4AT until the seventh day post-TAVI and then twice weekly thereafter	Daily (during inpatient admission) until the seventh day post-TAVI and then twice weekly thereafter
Secondary	Changes in health-related quality of life	Measured using EQ-5D-5L at baseline and 30 days post discharge via telephone	30 days
Secondary	Changes in physical frailty	By comparing SARC-F (strength, assistance with walking, rise form a chair, climb stairs and falls) questionnaire at baseline and 30 days (via telephone) after discharge	30 days
Secondary	Changes in physical frailty	By comparing dominant handgrip strength at admission and discharge - average of 3 trials of maximal isometric grip measured in kilograms using a Jamar hydraulic hand dynamometer (Anatomy Supply Partners LLC, Georgia, USA).	On discharge: e.g. 2-7 days
Secondary	Changes in physical frailty	By comparing timed chair rises at admission and discharge - time (measures in seconds) to complete five chair rises without using arms.	On discharge: e.g. 2-7 days
Secondary	Change in cognitive function	Assessed using T-MoCA at admission and 30 days post discharge via telephone	30 days
Secondary	Change in mood	Assessed using HADS at admission and 30 days post discharge via telephone	30 days
Secondary	Incidence of falls during hospitalisation		On discharge: e.g. 2-7 days
Secondary	Length of hospital stay	Duration of inpatient stay at tertiary centre	On discharge: e.g. 2-7 days
Secondary	Discharge destination	e.g. to patient's own home, long-term care facility or district general hospital	On discharge: e.g. 2-7 days
Secondary	Unplanned readmissions	Measured at 30 days post discharge from tertiary centre using hospital records and patient telephone-interview	30 days
Secondary	Mortality	Measured at 30 days post discharge using hospital records and NHS Spine database	30 days